Penza

Researchers are evaluating the effects of long-term lipid-lowering therapy in patients who have experienced a primary ST-segment elevation myocardial infarction STEMI or non-STEMI NSTEMI. This study, conducted at a single center, plans to include 300 hospitalized patients meeting specific criteria. The research aims to assess various heart and vascular functions, including electrical myocardial heterogeneity, myocardial deformation, vascular stiffness, and quality of life over an extended period. Participants initially receive atorvastatin at a dose of 80 mg daily within 24 to 96 hours after acute myocardial infarction AMI alongside standard therapy, which may include dual antiplatelet therapy, ACE inhibitors, beta-blockers, and other medications as needed. If LDL cholesterol levels do not reach target thresholds after 5-6 weeks, ezetimibe 10 mg once daily is added. The study follows patients for a total of 96 weeks, monitoring changes and responses to treatment. During the study, participants undergo detailed assessments including blood tests, advanced echocardiography to evaluate heart muscle movement, long-term ECG monitoring for heart rhythm and electrical stability, ultrasound of arteries to assess stiffness and structure, and flow-mediated dilation tests for endothelial function. Functional tests like the six-minute walk and pulse oximetry are performed. Quality of life, anxiety, depression, physical activity, and treatment adherence are also evaluated through questionnaires. The primary outcomes include measures of ventricular arrhythmias, heart function, myocardial deformation, and electrical instability over up to 48 months, with additional monitoring of cardiovascular events and quality of life.

Researchers are evaluating clinical outcomes for patients who begin inclisiran treatment within about two weeks after experiencing a heart attack STEMI or non-STEMI. This observational study focuses on patients in Russia and aims to understand the effects of inclisiran on lipid profiles, safety, atherosclerotic plaque status using carotid ultrasound, and the rates of hospitalizations and intensive follow-up over a 12-month period. Participants receive their first inclisiran injection approximately 14 days after their heart attack. The study observes changes in lipid levels at baseline, 3, 9, and 12 months, as well as plaque progression or regression over the year. Researchers also monitor adverse events, therapy discontinuation, hospital readmissions, emergency care visits, and the timing of dispensary observation. During the 12 months of participation, patients undergo lipid profile testing, carotid ultrasound scans, and safety evaluations at specified intervals. The main measure is the number of patients experiencing atherosclerotic cardiovascular disease events within a year after starting inclisiran in addition to their usual therapy. Secondary assessments include LDL cholesterol levels, plaque changes, adverse events, rehospitalizations, and use of emergency services, all tracked to evaluate the therapys impact and safety in real-world settings.

Researchers are evaluating the safety and effectiveness of a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.

This research aims to study the safety and effectiveness of a drug called non-immunogenic staphylokinase in patients with massive pulmonary embolism, a serious condition involving blood clots in the lungs. The study builds on previous trials that found this drug to be as effective as alteplase with fewer major bleeding events, making it a promising emergency treatment option. The study is observational and focuses on patients receiving this drug in routine clinical practice. Participants receive a single intravenous bolus dose of 15 mg non-immunogenic staphylokinase Fortelyzin4 regardless of body weight. This drug is easy to administer quickly in emergency situations and is used for treating massive pulmonary embolism since 2024. The study collects information on patients treated with this drug to assess outcomes in a real-world setting. During the study, participants are monitored for outcomes such as all-cause mortality at 7 and 30 days after drug administration, hemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure changes. Safety is closely observed, especially for bleeding events. The study runs from June 2025 to December 2027, with ongoing evaluation of participants following treatment in routine care.

Researchers are evaluating the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients aged 18 to 75 years. This multicenter, double-blind, placebo-controlled, randomized clinical trial focuses on adults experiencing symptoms within 48 hours of disease onset during the seasonal peak of acute respiratory viral infections. The study aims to compare Raphamin against placebo in improving symptoms and quality of life. Participants will be randomly assigned to one of two groups at the first visit. One group receives Raphamin tablets dissolved in the mouth following a specific dosing schedule over 5 days, starting with multiple doses on day 1 and three times daily thereafter. The other group receives a placebo on the same schedule. The study includes a treatment period of 5 days and follow-up visits up to 14 days. Participants will attend three visits on days 1, 4, and 7, either at a medical center or at home, with a phone visit on day 14. They will complete symptom severity scales and quality of life questionnaires, record daily temperature and symptoms in an electronic diary, and report any worsening condition or adverse events. Researchers will monitor symptom improvement, safety, antibiotic use, hospitalizations, and vital signs throughout the study and follow-up period.

This research aims to evaluate the safety and effectiveness of Reamberin solution for infusion, 1.5%, as a treatment for viral enteric infections in children aged 1 to 6 years. The study focuses on children of both sexes who have been diagnosed with viral intestinal infections and show clinical signs of intoxication. The goal is to assess the use of this drug in routine clinical practice for pathogenetic therapy. Participants receive either Reamberin at a daily dose of 10 mLkg combined with normal saline or glucose solutions, or standard infusion therapy such as normal saline, Ringers solution, or glucose solutions alone. The study is observational and open, with treatment decisions made by physicians, and it monitors the patients during the course of infusion therapy. Children enrolled in the study will be closely monitored for various health outcomes including the duration of infusion therapy, symptoms related to gastrointestinal tract damage, intoxication, fever, and hospital stay length. Assessments will be made at 24 and 48 hours after treatment begins and on day 10 to evaluate therapy continuation, symptom dynamics, electrolyte balance, dehydration severity, and blood parameters. The total study participation spans these key timepoints to track the therapys impact and safety.